Risperdal, a prescription medication used to treat schizophrenia and bipolar disorder, has caused gynecomastia, or the development of female breast tissue, according to leading plaintiff’s lawyer Derek T. Braslow of Pogust, Braslow & Millrood in Conshohocken, PA. This condition resulted from elevated levels of the hormone prolactin in the plaintiffs – which they allege is from their use of Risperdal.

The litigation has been continuing for three years, with 2,000 plaintiff cases filed in Philadelphia and the next trial set for January. Another 16,000 case are consolidated in California Superior Court in Los Angeles with the first trials set for July. Three earlier trials have resulted in verdicts in favor of the injured plaintiff in the amount of $2.5 Million, $1.75 Million, and $500,000. In all the trials, juries have found that J&J failed to adequately warn of the risks of gynecomastia.

Kentucky Attorney General Jack Conway announced a $15.5 million settlement in December 2015 with Johnson & Johnson regarding Risperdal. The consumer protection lawsuit charged that Johnson & Johnson falsely marketed the drug and hid the side effects from consumers.

Former commissioner of the U.S. Food & Drug Administration (FDA) David Kessler testified in 2015 that the company hid information about the gynecomastia risk as early as 6 years before it changed the drug’s label to include the injury, which is characterized by abnormal breast tissue growth in adolescent boys and young men. He also told the jury that Janssen failed to inform physicians of the gynecomastia risk associated with the drug.

Scientific research supports claims that Risperdal may cause gynecomastia in boys. A study published in a 2006 issue of the Journal of Clinical Psychopharmacology indicated that risperidone, which is the generic of Risperdal, “administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia.”

Braslow said that J&J has been settling Risperdal cases, but the amounts are not disclosed. The highest settlements are for boys who undergo double mastectomy. He advised plaintiff lawyers to focus on cases involving prescriptions written from 2000 to 2006.

Risperdal has carried a black-box warning by the FDA since September 2006 to warn about the increased risk of death in elderly patients with dementia-related psychosis. In addition to the increased risk of death in the elderly, Risperdal has added warnings associated with Tardive Dyskinesia, which is the development of abnormal facial, shoulder and limb movements that a patient cannot control.

Mass Tort Litigation has emerged as the only effective check on pharmaceutical and medical device companies that make dangerous products injuring thousands of Americans. Mass tort attorneys have filed 140,000 lawsuits in 250 federal multidistrict litigation dockets as of September 2016.

Many attorneys are expanding their personal injury practices to include mass torts because the US Judicial Panel on Multidistrict Litigation has organized the litigation so effectively against the multi-billion-dollar drug and medical device industry.

“The FDA is not a check or a balance on the pharmaceutical industry,” said Mass Tort Nexus Consultant John Ray, recently teaching a four-day course about mass torts in Fort Lauderdale, FL. “Plaintiff attorneys are the only check on the pharmaceutical industry.”

In recent years mass tort lawyers have recovered $10 billion in settlements for injured Americans: $4.8 billion for Vioxx, $1.8 billion for Yaz, $1.3 billion for the Stryker hip and $2.5 billion for the DePuy hip.

“The drug companies bake these cases into their business model,” Ray said. “Defendants call it a win when they don’t put a warning on their labels, don’t get sued and don’t have to pay a judgment at all. This means they got away with it. That happens a lot.”

When a federal MDL is created, the supervising judge will approve a standard short-form or long-form complaint, plus a plaintiffs’ fact sheet which replaces interrogatories. The consolidation of cases means that a mass tort lawyer can file a notice of appearance and file cases regardless of the jurisdiction of the plaintiff, defendant company or the location of the plaintiff’s attorney.

Criteria for a viable case

Cases that are attracting many mass tort attorneys now involve Xarelto, IVC filters and Pradaxa. Among the many factors determining the viability of a mass tort are:

Statute of limitations: State laws govern when the statute of limitations starts to run, but in most federal litigation, the date that the FDA issues a “black box warning” for a drug marks the date when the time limit begins to run.

Legal viability. In many cases, research will show a connection between a drug and injuries among patients, but specific causation must be proved in a trial. Experts must be found who will survive a Daubert motion to disqualify.

Financial viability of the defendant. While Johnson & Johnson had $46.8 billion in annual income in 2015, some small makers of IVC filters went out of business before they could sell one.

Cost per client acquired. Costs can add up with Facebook advertising, website marketing, and lead generation companies. For example, The Sentinal Group will advertise for clients for a fee of $100,000 to obtain 250 calls for Xarelto plaintiffs, with 1 out of 5 calls leading to a signed client.

Case duration. Mass torts are litigation for the long haul, with the average case lasting 5 years and 4 months before settlement, according to Ray, with 7 years being a good benchmark for the duration of a case.

Case value. An example of a good outcome is with Pradaxa. The average settlement is $162,000. Calculating 40% in gross contingent fees would equal $64,800. Another 7% is deducted ($4,536) for the common benefit to pay the steering committee. Of the remaining fee of $60,204, a 40% referral fee of $24,015 is deducted for the co-counsel that handled the litigation. This leaves a net fee of $36,189 for the attorney who originated the case.

Financial resources. Costs to fund a case can be in the tens of thousands of dollars, with costs reaching hundreds of thousands for members of the plaintiffs steering committee.

Personnel resources. A law firm will have to train a small army of intake specialists to answer incoming calls when advertising is running. Additional personnel will be needed to obtain and review medical records.

Perfect timing

There are three phases of mass tort litigation, and perfect timing will be needed to enter a particular case.

Emerging Phase Cases. In this early phase, the cost to acquire a client is the least expensive, but there many issues of case viability. For example, the courts are still considering motions to consolidate cases involving Abilify and Roundup. With Abilify the FDA has issued a safety warning but not a black box warning. With Roundup the EPA has not classified the herbicide as a carcinogen, but foreign governments have.

Litigation Phase Cases. It is considered an ideal time to enter into a mass tort when the JPML has created a multi-litigation docket (MDL). Some 250 MDLs include mature litigation involving Benicar, Lipitor, Viagra, Xarelto and Zofran, and many legal issues have been settled. The supervising judge will schedule bellwether or test cases for trial.

Settlement Phase Cases. This is the very safest time to enter litigation because all an attorney must do is find qualified plaintiffs. Example cases involve transvaginal mesh, Levaquin and Pradaxa. However at this late phase the cost to acquire a client is at its highest.

“Whatever you do, maintain your single-event plaintiff’s practice,” Ray advised. “You will have to keep paying the costs of a mass tort case until it settles, and you will need a huge cash supply or credit line.”

More than 3,500 personal injury and wrongful death cases are currently pending US District Court for the Southern District of Ohio in MDL 2433 about the cancer-causing chemical C-8 that discharged from DuPont’s Washington Works Plant into the water supply in West Virginia.

The US Judicial Panel on Multidistrict Litigation created the Multidistrict Litigation docket on April 9, 2013. Judge Edmund A. Sargus, Jr., Chief US District Judge is supervising the docket, IN RE: E. I. du Pont de Nemours and Company C-8 Personal Injury Litigation.

Probable link to cancer

Over many years du Pont discharged the chemical C-8 used to make Teflon (also known as perfluorooctoanoic acid (PFOA) or ammonium perfluorooctanoate (APFO) into the Ohio River water supply. The plaintiffs allege that they suffer or suffered from one or more of six diseases — including kidney tumors and testicular cancer.

A “Probable Link” to C-8 exposure finding was made after a study conducted as part of a 2005 settlement between DuPont and a class of about 80,000 persons who consumed water from six water districts allegedly contaminated by C-8 from the Washington Works Plant. See Leach v. E.I. Du Pont de Nemours & Co., No. 01-C-608 (W. Va. Cir. Ct.).

On July 6, 2016 jurors ruled that DuPont acted with malice by dumping chemical-tainted water from its West Virginia plant into the Ohio River, causing Marietta College professor David Freeman to get cancer and awarded him $5.1 million in compensatory damages.

In October 2015, a different jury returned a $1.6 million verdict in favor of a woman who also said she got cancer because of drinking water contaminated with C8. Carla Bartlett of Guysville, Ohio, was awarded $1.1 million in damages for DuPont’s negligence and $500,000 for emotional distress, but did not receive any punitive damages. That verdict is being appealed.

One of the final images of beloved golfer Arnold Palmer is the 87-year old in a TV commercial wearing a pink sweater and saying, “Treatment with Xarelto was the right move for us.” Many people are wondering if that is true in the wake of his death on September 25, 2016, which was preceded in August 2016 by surgery for colon bleeding, according to Golf Digest.

Xarelto is the target of 10,769 federal and state lawsuits that charge, among other things, that the blood-thinning drug causes death from gastrointestinal and other internal bleeding. Palmer was hospitalized on Sept. 22 in preparation for heart surgery on Sept. 26 at Pittsburgh Medical Center. However, his conditioned steadily weakened and he died “due to complications from heart disease.”

Despite ongoing federal and state litigation, defendants Bayer HealthCare AG and Janssen Pharmaceuticals have broadcast a TV commercial for more than a year, where Palmer and other celebrities tout the dangerous drug.

Just 25 months ago Palmer underwent surgery to have a pacemaker implanted, according to Golf Digest. That procedure marked the first of a series of health issues including high blood pressure, for which he took pills daily. Palmer said in a 2015 interview that he was taking “a blood thinner,” which he attributed to a bout with deep vein thrombosis (blood clots). Deep vein thrombosis is linked with coronary heart disease. Had he been taking Coumadin he would not have needed surgery to stop the colon bleeding.

Defendants in the federal MDL, before US District Judge Eldon E. Fallon, In RE: Xarelto (Rivaroxaban) Products Liability Litigation, include Bayer Healthcare, the designer and manufacturer of Xarelto. Janssen Pharmaceuticals (a Division of Johnson & Johnson) currently sells Xarelto in the United States pursuant to a licensing agreement with Bayer. Plaintiffs involved in the MDL have suffered various harmful side effects, including:

In addition, 13 Abilify compulsive behavior lawsuits pending in New Jersey state court have been consolidated in one proceeding for pretrial coordination. In total, Plaintiffs’ counsel anticipate that hundreds of additional Abilify compulsive behavior cases will be filed.

24 million patients

Since its U.S. launch over 13 years ago, an estimated 24 million patients have used Abilify with sales in 2013 totaling $2.3 billion. Doctors widely prescribe it to treat patients with schizophrenia, bipolar disorder, and major depressive disorder. The defendants are Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc.

The movants recommend the new MDL be supervised by Judge Margaret Catharine “Casey” Rodgers in Pensacola, FL, before whom two Abilify compulsive behavior cases are pending. There are no MDLs pending in the Florida courthouse.

Denise Miley and Brad Miley of Maple Grove, Minnesota, filed the first lawsuit on January 12, 2016, in the District of Minnesota, Miley v. Bristol-Myers Squibb Company, Case 0:16-cv-00067.

Abilify was introduced in 2002 as an atypical anti-psychotic prescription medicine discovered by Defendant Otsuka Pharmaceutical Co., Ltd. In November 2012, the European Medicines Agency required that the defendants warn patients and the medical community in Europe that Abilify use included the risk of pathological gambling.

Warnings since 2012

Agencies began issuing warnings in 2012:

In November 2012, the European Medicines Agency required that the defendants warn patients and the medical community in Europe that Abilify use included the risk of pathological gambling.

In November 2015 Canadian regulators concluded that there is “a link between the use of aripiprazole and a possible risk of pathological gambling or hypersexuality.”

On May 3, 2016, the FDA, in an “FDA Safety Communication,” announced that warnings about “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex” would be added to the Abilify label. From 2005 to 2013, an FDA report showed that Abilify accounted for at least fifty-four reports of compulsive or impulsive behavior problems, including thirty reports of compulsive gambling, twelve reports of impulsive behavior, nine reports of hypersexuality, and three reports of compulsive shopping.

Among the issues that must be decided in a case are:

Whether and to what extent Abilify is a substantial factor in causing the alleged compulsive behavior.

When Defendants learned of any such connection between Abilify and the alleged compulsive behavior.

Whether, and for how long, Defendants concealed any such knowledge from prescribing physicians.

Whether Defendants failed to provide adequate and timely warnings and instruction about the alleged relationship between Abilify and compulsive behavior.

Whether Defendants engaged in fraudulent and illegal marketing practices including, but not limited to, making unsubstantiated claims about the effectiveness and superiority of Abilify.

Whether Defendant Otsuka Pharmaceutical Co, Ltd. is subject to personal jurisdiction in the United States courts.

US District Judge John W. Lungstrum in Kansas certified nine class actions brought by virtually every corn producer in America who suffered a dramatic loss in the value of their crops in 2013 when Syngenta AG shipped genetically-modified corn to China, which responded by banning all US corn.

The National Grain & Feed Association pegged the market-wide losses at $6.3 billion through August 2015 when China turned away at least 1.45 million metric tons of corn starting in November 2013. It contained genetic trait MIR 162 developed by Syngenta, of Basel, Switzerland, and that variety wasn’t approved by China.

The judge appointed class counsel to be attorneys Don M. Downing of Gray Ritter & Graham, PC in St. Louis, Patrick J. Stueve of Stueve Siegel Hanson LLP in Kansas City, Scott Powell of Hare Wynn Newell & Newton in Birmingham, AL, and William Chaney of Gray Reed & McGraw in Dallas. They are also lead counsel in the federal MDL litigation.

Judge Lungstrum certified a nationwide class to pursue the Lanham Act (false advertising) claims and certification of eight statewide classes (consisting of producers in Arkansas, Illinois, Iowa, Kansas, Missouri, Nebraska, Ohio, and South Dakota) to pursue negligence claims, as well as tortious interference claims in the Arkansas and Missouri classes, and statutory consumer protection claims in the Illinois and Nebraska classes.

Tens of thousands of plaintiffs

Some 800 federal cases are pending in the multidistrict litigation docket, MDL 2591, before Judge Lungstrum. On top of that:

Three more federal actions, involving more than 2,800 plaintiffs, are pending in the United States District Court for the Southern District of Illinois before U.S. District Judge David R. Herndon.

Approximately 2,375 cases, involving over 20,000 plaintiffs, are pending in the Fourth Judicial District of Hennepin County, Minnesota, and consolidated before Judge Thomas M. Sipkins in a case captioned In re Syngenta Litigation, No. 27-cv-15- 3785.

In addition, about 200 cases are pending in the Illinois First Judicial Circuit Court before Judge Brad K. Bleyer.

China imports 4 million metric tons of corn per year, and corn is the largest crop export from of the US. Knowing that the clock was ticking on the expiration of its Agrisure Viptera GMO corn patent, Syngenta aggressively commercialized the crop from 2011 to 2014. Despite warnings from industry participants that China had not approved the GMO corn, U.S. exports to China were found to be contaminated with MIR162. China then began rejecting shipments of corn from the U.S.

“These events show corporate greed at its worst. But there is more. To attempt to minimize the perceived impact of its conduct, Syngenta actively misled farmers, industry participants and others about the importance of the Chinese market, the timing and substance of its application for approval in China, the timing of when China was likely to approve MIR162, its ability to “channel” Viptera® to non-Chinese markets and otherwise contain the infiltration of Viptera® into the U.S. corn supply,” the class action complaint states.

Judge Lungstrum rejected all of Syngenta’s arguments against class certification. The company argued unsuccessfully that the terms “corn priced after November 18, 2013” and the term “producer” were vague. The judge said “priced” simply means the date when the price for particular corn is agreed upon by parties for sale, and that producer was defined by the USDA’s Farm Service Agency. The judge also rejected Syngenta’s argument that the proposed classes were overbroad.

The court added that the plaintiffs do have a class-wide method to show damages and have experts who have created models to determine the per-unit effect on class members’ sales of corn.

“The Court does not foresee any particular difficulties in the management of class actions, and … ascertaining the class members in this case does not require difficult individualized inquiries,” the judge wrote.

The request to the Judicial Panel on Multidistrict Litigation is a critical first step in turning individual claims into a wide-reaching mass tort.

Currently, there are at least 56 actions pending in 11 different judicial districts alleging similar wrongful conduct on the part of defendants.

The movants propose the judge should be US District Judge Brian R. Martinotti in New Jersey, in part because Janssen and its parent company Johnson & Johnson are headquartered in the state. Judge Martinotti has supervised litigation involving Mirena, Yaz, Yasmin and the DePuy Hip, and has 36 of the Invokana cases already on his docket.

1.5 million prescriptions

The motion follows a safety warning by the FDA on June 17 strengthening the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, the FDA revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.

Further warnings were added to the label in August 2016. The new warnings stated that fatal cases of ketoacidosis have been reported in patients taking Invokana. The FDA advised doctors to inform patients that ketoacidosis is a serious life-threatening condition.

In the year from October 2014 to September 2015, 1.5 million prescriptions were written for either canagliflozin or dapagliflozin.

“SGLT2 inhibitors, including Invokana, are designed to inhibit renal glucose reabsorption with the goal of lowering blood glucose. As a result, excess glucose is not metabolized but instead is excreted through the kidneys of a population of consumers already at risk for kidney disease,” the motion states. “Though Invokana is indicated for only improved glycemic control in type 2 adult diabetics, defendants have marketed and continue to market Invokana for off-label purposes, including but not limited to weight loss, reduced blood pressure, and improved glycemic control in type 1 diabetics.”

“Defendants engaged in aggressive, direct-to-consumer and physician marketing and advertising campaigns for Invokana. However, consumers of Invokana were misled as to the drug’s safety and efficacy, and as a result have suffered serious and dangerous injuries,” the motion states.

The motion was filed by Christopher A. Seeger and Jeffrey Grand of Seeger Weiss LLP in New York. Notices of appearance in the MDL are due by Oct. 5 and responses to the motion are due by Oct. 12.

The judge overseeing federal Xarelto product liability litigation ordered defendant Bayer to turn over the personnel records of two doctors on its payroll who can testify about plaintiff claims that the blood-thinner drug was rushed to the market.

The plaintiffs also seek the records because they may contain evidence of aggressive compensation schemes or rush-to-the-market liability, which is vital to their case-in-chief.

US District Judge Eldon E. Fallon ordered the company to turn over redacted copies the personnel files of Dr. Dagmar Kubitza, Head of Clinical Pharmacodynamics, and Frank Misselwitz, Corporate Vice President, both working in Germany. Excluded from the records are performance reviews, evaluations for promotion and self-assessments.

Evasiveness by Bayer

“The Court is concerned by the evasiveness exhibited by Bayer in certain depositions and is troubled by the possibility of further evasive responses by deponents,” Judge Fallon wrote. “As this is a nationwide MDL, the rights of thousands of American citizens hinge on the timely production of materials that fall within the scope of the Federal Rules of Civil Procedure.”

Thousands of case filings are increasing court dockets in the Xarelto mass tort litigation in federal court and also the Philadelphia Court Of Common Pleas. Only claims involving hemorrhagic strokes (caused by internal bleeding, not a blood clot) can be brought in the federal MDL. As a result, thousands of ischemic stroke cases have been filed in the Philadelphia before Judge Arnold L. New.

Defendants in the MDL include Bayer Healthcare, the designer and manufacturer of Xarelto. Janssen Pharmaceuticals (a Division of Johnson & Johnson) currently sells Xarelto in the United States pursuant to a licensing agreement with Bayer. Plaintiffs involved in the MDL have suffered various harmful side effects, including:

The US Judicial Panel on Multidistrict Litigation reported that 700 product liability lawsuits have been filed as of Sept. 15 in federal court in Minnesota against 3M Company involving its Bair Hugger forced-air warming blanket used in hip or knee surgery.

The actions share factual issues arising from allegations that plaintiffs developed serious infections during their orthopedic surgeries due to the introduction of contaminants into their open wounds as a result of the use of a Bair Hugger system.

The plaintiffs allege that the device is defective in two respects:

The device affects airflow in the operating room, causing bacteria from the operating room floor to be deposited into the surgical site.

The internal airflow paths of the device’s blower can become contaminated with pathogens that can then be expelled into the operating room.

Deep joint infection

The actions present common issues concerning the development, manufacture, testing, regulatory approval process, and marketing of the Bair Hugger blanket. The plaintiffs developed a deep joint infection after hip or knee implant surgery. 3M is accused of ignoring the flaw for years, and of failing to make design changes or provide appropriate safety warnings to the medical community.

In pretrial order No. 13 on Sept. 9 the court set out an amended scheduling order governing discovery, proposals for short form complaints and plaintiff fact sheets, and setting the first bellwether trial for November 6, 2017. The next status conference will be held on October 13, 2016. Starting in November 2016, the regularly scheduled status conferences shall be held on the third Thursday of each month.

The US Judicial Panel on Multidistrict Litigation will hear arguments this month on consolidating 18 actions pending in federal courts across the country where the plaintiffs allege that use of cosmetic talc products made by Johnson & Johnson causes ovarian cancer.

The Georgia/Florida Talc Plaintiffs argue for consolidation before Judge Clay D. Land, Chief Judge for the Middle District of Georgia, where at least four related actions are already pending. Represented by the Barnes Law Group of Marietta, GA, and the Cheeley Law Group in Atlanta, the plaintiffs are Cammy and Michael A. Marchetti, Nancy Crews Hicks and Brannon Rice Hicks, Sr., and Allison Walker.

Plaintiff Tanashiska Lumas argues for consolidation before David R. Herndon in Southern District of Illinois. Her attorneys are with The Barrett Law Group in Lexington Mississippi. The judge is in charge of two MDLs, for Pradaxa and Yasmin.

Defendant Johnson & Johnson argues for consolidation before Judge Freda Wolfson in the District of New Jersey, where Chakalos v. Johnson & Johnson, No. 3:14-cv-07079, is pending. J&J is headquartered in New Brunswick, New Jersey, and the judge previously presided over three MDLs for Plavix, Fosamax and Southern Life Insurance.

In the alternative, J&J argues for transferring the cases before Judge Timothy DeGiusti in the Western District of Oklahoma, where Robb v. Johnson & Johnson, No. 5:16-cv-00620, is pending. He is not presiding over an MDL.

8-figure verdicts

J&J is facing 1,200 lawsuits in Missouri and New Jersey, charging it with failing to warn consumers about the cancer risks. Earlier this year juries in state court in St. Louis awarded 8-figure verdicts in trials charging that the company knew that its talc-based products cause ovarian cancer, and failed to warn women who used it.

In May 2016 a jury awarded plaintiff Gloria Ristesund of Sioux Falls, SD, $55 million in damages. Talc was found in the ovarian tissue after a she had a hysterectomy. She was diagnosed with cancer in 2011 after using J&J’s talc-based feminine hygiene products for almost 40 years. In February another jury in the same courthouse awarded $72 million to the family of Jacqueline Fox of Birmingham, AL, who used Johnson’s baby powder for 35 years. She was diagnosed with ovarian cancer in 2013 and died last year.

Using a the self-created Talc Interested Party Task Force, J&J hired scientists to perform biased research about the safety of talc, members of the TIPTF edited scientific reports prior to submission to government agencies, members of the TIPTF knowingly released false information about the safety of talc to the public, and used political and economic influence on regulatory bodies about talc.